Atobe Hadiphar prevents atherosclerosis, stroke (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Atorvastatin, Ezetimibe
Ingredient Ha Tinh Pharmaceutical Joint Stock Company - Vietnam

Ingredient

Composition information	Content
Atorvastatin	10mg
Ezetimibe	10mg

Uses

indications

ATOBE drug 10mg/10mg indicated treatment in the following cases:

The treatment of lipid changes should only be one of the interventions in people with high risk of atherosclerosis due to blood cholesterol.

Atobe 10mg/10mg is indicated to reduce total cholesterol, low density lipoprotein cholesterol (LDL-C), apolipoprotein B (APO B), triglyceride (TG), choleterol lipoprotein is not high, and high-rise lipoprotine cholesterin (HDL-C) in patients with hyperlipidemia has a family of blood lipid hypertension No family or hyperlipidemia mixed. Learning

ATC code: C10BA05

Pharmacological group: HMG inhibitor HMG Reductase combined with other lipid changes.

Clinical research has shown that total cholesterol, low density cholesterol-lipoprotein (LDL-C) and apolipoprotein B, the main protein components of low density lipoprotein (LDL), are the cause of atherosclerosis. In addition, the reduction of high density cholesterol-lipoprotein (HDL-C) is associated with the development of atherosclerosis.

Epidemiological research has shown that the incidence of cardiovascular disease and death increases proportional to total cholesterol growth and low density cholesterol-density cholesterol and inversely proportional to the increase in high density cholesterol-liprotein levels. Like the low density lipoprotein, the density lipoprotein is very low (VLDL), and the average density lipoprotein (IDL) can also promote atherosclerosis.

atorvastatin

enzyme HMG-CoA Reductase catalyzes the synthesis of cholesterol from Acetyl CoA. Atorvastatin inhibits competition with this enzyme, which reduces cholesterol. Atorvastatin also increases LDL-detailor in cell membranes, helps enter LDL into cells and eliminates lipids through enzymes in Lysosom.

Atorvastatin has been shown to reduce cholesterol (30% - 46%), LDL -C (41% - 61%), Apolipoprotein B (34% - 50%), and triglycerides (14% - 33%) while increasing HDL -C and Apolipoprotein Al in a dose research study.

These results are suitable for patients with hypercholester hyperplasia patients with heterozygous and hyperlipidemia mixed blood lipids, including diabetic patients regardless of insulin.

Low cholesterol, low density cholesterol, cholesterol-lipoprotein (LDL-C) and apolipoprotein B have been shown to reduce the risk of cardiovascular complications and cardiovascular death.

ezetimib

Ezetimib reduces blood cholesterol by inhibiting the absorption of cholesterol of the small intestine.

Ezetimib does not inhibit cholesterol synthesis in the liver, or increase bile secretion. Instead, Ezetimib works in the brush of the small intestine and inhibits the absorption of cholesterol, resulting in reducing the amount of cholesterol absorbed from the small intestine and transporting to the liver.

This reduces cholesterol reserves in the liver and increases cholesterol from blood. This difference mechanism is supplemented for statins and fenofibrats.

Dynamic pharmacokinetics

absorption

Atorvastatin is quickly absorbed. The absorption of the drug is not affected by food.

Birth of Atorvastatin is low because it is strongly metabolized through the liver for the first time (over 60%).

The peak concentration of serums of active substances achieved after 1-4 hours.

After drinking, Ezetimib is absorbed and combined to create a conjugate form of Ezetimib-Glucuronid. The absorption of the drug is not affected by food.

distribution

Atorvastatin: The distribution volume of the drug is about 381 liters, the ratio of binding to plasma protein> 98%.

ezetimib: The ratio of binding to the plasma protein of ezetimib and the Ezetimib-Glucuronid complex is> 90%.

metabolism and elimination

atorvastatin:

Atorvastatin is widely metabolized to create Ortho derivatives, parahydroxylated derivatives and different beta-oxidation products.

In In vitro research, the HMG-Coa Reductase inhibitor by Ortho and parahydroxylated metabolites equivalent to Atorvastatin.

About 70% of HMG-CoA Reductase reducing enzymes are due to active metabolites.

Atorvastatin and its metabolites are excreted mainly through the liver or the liver metabolism. The drug does not go through the gut cycle.

Atorvastatin's semi-exhaust time is about 14 hours, but the half-life of HMG-CAA reducing enzymes is 20-30 hours due to the contribution of the metabolites. Less than 2% of Atorvastatin dose is found in urine after drinking.

ezetimib:

Ezetimib is mainly metabolized in the small intestine and liver thanks to glucuronid complex with bile and excreted by the kidneys.

In humans, Ezetimib quickly transformed into Ezetimib-Glucuronid. Ezetimib and Ezetimibe-Glucuronid are the main active ingredients detected in plasma, accounting for about 10-20% and 80-90% of the total number of drugs in plasma, corresponding.

Both Ezetimib and Ezetimib-Glucuronid are removed from plasma with the semi-discharged cycle of about 22 hours. There are many times when the drug reaches the peak concentration in the blood, shows that there may be a process of re -absorption in the intestine.

Before taking Atobe Hadiphar prevents atherosclerosis, stroke (3 blisters x 10 tablets)

How to use

Atobe 10mg/10mg Tablets Film tablets for oral, can be taken with or not with meals.

Do not chew or dissolve the drug when taken.

Dosage

Dosage recommended: Take 1 capsule/day.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose? In case of overdose, patients need to be treated with symptoms and supported treatment depending on the condition.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

Unwanted effects (ADR) when using Atobe 10mg/10mg that you can meet.

Blood disorders and thrombocytopenic systems, HBA1C.

Nervous system disorders: headache, paresthesia; Peripheral neuropathy.

Cognitive decline (for example, dementia, or forgetfulness, memory impairment) involves the use of statin. Gastrointestinal disorders: pancreatitis.

Hyperglycemia.

Disordered skin and tissue: Evaluation; Water ball rash (including diverse roses, Stevens-Johnson syndrome and toxic epidermal necrosis); rash, urticaria.

Bone and tissue muscle disorders: muscle or muscle disease.

Immune system disorders: Anaphylaxis; Hypersensitivity reaction.

Hepatitis disorders: hepatitis, gallstones; cholecystitis; Liver failure and death.

Mental disorders: depression.

Abnormal tests: Increased creatin phosphokinase.

When experiencing side effects of the drug, patients need to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

contraindicated

ATOBE drug 10mg/10mg contraindicated in the following cases:

Liver disease is progressing or increasing persistent liver enzymes for unknown reasons.

Pregnant women, nursing women.

Be cautious when using

The rare case of the pattern with the secondary acute renal failure Myoglobinuria has been reported to Atorvastatin and with other drugs in this group.

History of renal failure may be a risk factor for the development of pattern.

These patients need to be closely monitored on the skeletal muscle effects.

liver enzymes

Checking liver enzymes should be performed before starting treatment with Atobe and during the use of the drug.

There have been reports on death and death without death patients using statins, including Atorvastatin.

If liver damage is seriously damaged with clinical symptoms or increased blood bilirubin or jaundice occurs when treated with ATOBE, it is necessary to suspend the use of the drug.

In case of not finding the cause of the above symptoms, the ATOBE use.

Atobe should be used carefully in patients who drink plenty of alcohol or have a history of liver disease.

contraindicated Atobe in patients with acute liver disease or persistent transaminase increased unknown cause.

Consider monitoring Creatin Kinase (CK) in the case:

Before treatment, CK tests should be conducted in the following cases:

impaired renal function, hypothyroidism, self -history or family history of genetic muscle disease, a history of muscle disease due to the use of statin or fibrat before, the history of liver disease and/or drinking lots of alcohol, elderly patients (> 70 years old) have risk factors for muscle pattern, the possibility of drug interactions and some special patients. Clinically monitoring patients when treated with statin. If CK test results> 5 times the upper limit of normal levels, do not start treatment with statin.

During statin treatment, patients need to notify when there are muscle manifestations such as muscle pain, hardening muscle, muscle weakness ... When these manifestations, patients need to do CK test to take appropriate interventions.

Endocrine function

HBA1C increase and plasma sugar levels have been reported with HMG-CoA Reductase inhibitors, including Atorvastatin.

Statin interferes with cholesterol synthesis and theoretically can repel steroid production in the adrenal or gonads.

The effects of statin on male fertility have not been studied in adequate quantities of patients.

influence, if any, on the pituitary-lust axis in pre-menopausal women.

Be cautious if Atobe is simultaneously used with drugs that can reduce the level or operation of endogenous steroid hormones, such as ketoconazole, spironolacton and cimetidine.

Use drugs for pregnant and lactating women

Do not use Atobe for pregnant women or nursing women.

The effect of the drug on the ability to drive, operate machinery

Caution when driving and operating machinery and drugs can cause headaches, blurring, dizziness ..

Interactive drug

Strong inhibitors Cytochrom P450 344

Atorvastatin is metabolized by cytochrom P450 3A4. Simultaneous use of Atorvastatin with strong CYP3A4 inhibitors can lead to an increase in the plasma concentration of Atorvastatin.

Because Atobe contains Atorvastatin, the risk of muscle disease when treated with Atobe increases when used simultaneously with erythromycin, otraconazole, ketoconazole, some protease inhibitors.

Protease inhibitors interact with Atorvastatin

tipranavir + ritonavir telaprevir: avoid using atorvastatin.

lopinavir + ritonavir: Use carefully and if necessary, the lowest atorvastatin dose should be used.

Darunavir + Ritonavir Fosamprenavir; Fosamprenavir + ritonavir; Saquinavir + ritonavir: not more than 20 mg atorvastatin/ day.

nelfinavir: not more than 40 mg atorvastatin/ day.

cyclosporin

Atorvastatin and its metabolites are the substrate of OATP1B1.

Oatp1b1 inhibitors (for example, cyclosporin) may increase the bioavailability of Atorvastatin. Atobe should be avoided with these substances.

gemfibrozil, fenofibrat, colchicin

Avoid using Atobe with Gemfibrozil, Fenofibrat, Colchicin due to increased risk of muscle diseases.

niacin

The risk of unwanted effect on skeletal muscles may be increased when Atobe is used in combination with niacin. When used with niacin, reduce the dose of Atobes to be considered.

digoxin

When concurrent use atorvastatin and multi -dose digoxin, plasma digoxin levels in a stable state increased by about 20%.

Patients who are using digoxin should be monitored appropriately.

Oral contraceptive pills

Simultaneous use of Atorvastatin and oral contraceptives increases the AUC value of Norethindron and Ethinyl Estradiol.

This increase should be considered when choosing birth control pills for a woman who is taking Atobe.

rifampin or other Cytochrom P450 3A4 enzyme induction

At the same time, Atorvastatin is concentrated with Cytochrom P450 3A4 (for example, Efavirenz, Rifampin) can reduce Atorvastatin's concentration.

Bile acid -mounted resins

Bile acid -mounted resins can significantly reduce Atorvastatin's bioactivity when taken. So the time to use these 2 drugs must be apart.

warfarin

Atorvastatin may increase the effects of warfarin.

Must determine prothrombin before starting Atorvastatin and regular monitoring in the early stages of treatment to ensure no change in prothrombin time.

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

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